A Phase 1 interventional study of AGN-242071 and Placebo in Alzheimer's Disease, sponsored by Allergan. Withdrawn at 6 sites in United States. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-11-02.
Sponsored by Allergan · Phase 1, Interventional, and Treatment
This is a study to evaluate the brain metabolic response using Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), safety, tolerability and pharmacokinetics of AGN-242071 in patients with mild to moderate Alzheimer's Disease on a stable dose of 10 mg donepezil with or without memantine standard of care.
Exclusion Criteria:
Two placebo capsules once daily for 28 Days. All participants are on a stable dose of 10 mg donepezil and, if receiving memantine, also on a stable dose of memantine as prescribed by the physician as per standard of care.
Drug: Placebo · Drug: Donepezil · Drug: Memantine
One AGN-242071 5 mg capsule plus one placebo capsule once daily for 28 days. All participants are on a stable dose of 10 mg donepezil and, if receiving memantine, also on a stable dose of memantine as prescribed by the physician as per standard of care.
Drug: AGN-242071 · Drug: Placebo · Drug: Donepezil · Drug: Memantine
AGN-242071 starting at a dose of one 5 mg capsule plus one placebo capsule once daily for 5 days followed by AGN-242071 15 mg total dose (one 5 mg and one 10 mg capsules) once daily on Days 6 to 28. Dose can be adjusted based on safety and tolerability. All participants are on a stable dose of 10 mg donepezil and, if receiving memantine, also on a stable dose of memantine as prescribed by the physician as per standard of care.
Drug: AGN-242071 · Drug: Placebo · Drug: Donepezil · Drug: Memantine
AGN-242071 starting at a dose of one 5 mg capsule plus one placebo capsule once daily for 5 days followed by AGN-24071 15 mg total dose (one 5 mg and one 10 mg capsules) once daily on Days 6 to 10 followed by AGN-242071 25 mg total dose (one 5 mg and one 20 mg capsules) on Days 11 to 28. Dose can be adjusted based on safety and tolerability. All participants are on a stable dose of 10 mg donepezil and, if receiving memantine, also on a stable dose of memantine as prescribed by the physician as per standard of care.
Drug: AGN-242071 · Drug: Placebo · Drug: Donepezil · Drug: Memantine
AGN-242071 capsules administered once daily to patients receiving donepezil 10 mg with or without memantine as prescribed per standard of care.
Placebo capsules once daily to patients receiving donepezil 10 mg with or without memantine as prescribed per standard of care.
Donepezil 10 mg as prescribed by the physician as per standard of care.
Memantine as prescribed by the physician as per standard of care.
Change from Baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Metabolic Measure of Standard Uptake Value Ratio (SUVR) for Whole Brain, Hippocampal and Dorsolateral Prefrontal Cortices
The effects of AGN-242071 on brain metabolic activity or glucose metabolism will be determined using the FDG-PET scan by reporting results as SUVR.
Time frame: Baseline (Day -3 to Day -1) to Day 28
Percentage of Participants with Treatment-Emergent Adverse Events (TEAE)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE that occurs during the treatment period will be considered a TEAE if it was not present before the first dose or if it was present but increased in severity during the treatment period.
Time frame: Day 1 to Day 35
Percentage of Participants with Changes from Baseline in Clinically Significant Clinical Laboratory Values
Clinical laboratory safety tests include Chemistry, Hematology and Urinalysis.
Time frame: Baseline (Day -3 to Day -1) to Day 35
Percentage of Participants with Changes from Baseline in Clinically Significant Vital Signs
Vital signs include systolic and diastolic blood pressure, pulse rate, weight, respiration rate, and temperature.
Time frame: Baseline (Day -3 to Day -1) to Day 35
Percentage of Participants with Changes from Baseline in Clinically Significant Electrocardiogram (ECG) Findings
A standard 12-lead ECG will be performed.
Time frame: Baseline (Day -3 to Day -1) to Day 35
Percentage of Participants who have Suicidal Ideation or Behaviours as determined by Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and suicidal behavior since the last visit.
Time frame: Baseline (Day 1) to Day 35
Clearance of AGN-242071
Clearance will be determined utilizing a population pharmacokinetic (PK) approach implemented in non-linear mixed effects modeling (NONMEM®) software.
Time frame: Day 1 to Day 28
Volume of Distribution of AGN-242071
Volume of Distribution will be determined utilizing a population PK approach implemented in NONMEM® software.
Time frame: Day 1 to Day 28
Cmax: Maximum Plasma concentration for AGN-242071
Time frame: Day 28
AUC: Area Under the Curve for AGN-242071
Time frame: Day 28
This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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